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RODOMEL XL 75 MG PROLONGED RELEASE CAPSULE HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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TEVA UK Ref:

231-30-86688-Y LEA VENLAFAXINE (RODOMEL) A/S CAP TUK
RODOMEL XL 37.5 mg PROLONGED
RELEASE CAPSULES, HARD
RODOMEL XL 75 mg PROLONGED
RELEASE CAPSULES, HARD
RODOMEL XL 150 mg PROLONGED
RELEASE CAPSULES, HARD
Venlafaxine
Package leaflet:
Information for the user
IMPORTANT THINGS YOU SHOULD KNOW ABOUT
RODOMEL XL
Please read all of this leaflet before you start to take
your medicine as it contains important information
about Rodomel XL
• Rodomel XL is used to treat depression, severe
and persistent anxiety known as generalised
anxiety disorder (GAD), social anxiety disorder
(also known as social phobia) and panic
disorder (panic attacks)
• Rodomel XL is not for use in children and
adolescents – see in section 2 ‘Use in children
and adolescents.’
If you have any concerns about how you feel, or
about this medication, it is important that you talk to
your doctor - even if you feel anxious or worried
about doing so.
You may find it helpful to tell a friend or relative that
you are depressed or suffering from an anxiety
disorder, and that you have been prescribed this
medication; it might be useful to show them this leaflet.
• Rodomel XL may not start to work immediately.
Some people taking antidepressants may feel
worse before feeling better. Your doctor may ask
to see you again a couple of weeks after you
start treatment and then regularly until you start
to feel well again. Tell your doctor if you do not
start to feel better.
• Some people who are depressed may think of
harming or killing themself. If this happens you
should see your doctor or go to a hospital
straight away – see in section 2 ‘Thoughts of
suicide and worsening of your depression or
anxiety disorder’
• If you take too many capsules it is important to
seek immediate medical attention, even if you
feel well, because of the risk of serious side
effects
• Do not stop taking Rodomel XL or change your
dose without the advice of your doctor even if
you feel better. If you stop taking Rodomel XL
abruptly you may get withdrawal reactions – see
in section 3 ‘If you stop taking Rodomel XL’
• If you have heart problems such as fast or
irregular heart rate or high blood pressure you
should talk to your doctor before taking
Rodomel XL – see in section 2 ‘Before you take
Rodomel XL’
• Taking certain other medicines with Rodomel
XL may cause problems. You should tell your
doctor if you are taking any other medicines –
see in section 2 ‘Before you take Rodomel XL
See your doctor without delay if you feel
restless and feel like you can’t keep still, feel
‘high’ or very over-excited, have jerky muscle
movements which you can’t control. See section
4 – ‘Possible side effects’ for other important
information’
• If you are pregnant, or intend to become
pregnant, or breast-feeding, you should talk to
your doctor – see in section 2 ‘Pregnancy,
breast-feeding and Rodomel XL.’
More information on all of these points is provided in
the rest of this leaflet.
Read all of this leaflet carefully before you start
taking this medicine, because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Rodomel XL is and what it is used for
What you need to know before you take Rodomel XL
How to take Rodomel XL
Possible side effects
How to store Rodomel XL
Contents of the pack and other information

1

WHAT RODOMEL XL IS AND WHAT IT IS
USED FOR

Rodomel XL is an antidepressant that belongs to a
group of medicines called serotonin and
norepinephrine reuptake inhibitors (SNRIs). This
group of medicines is used to treat depression and
social anxiety disorder. It is thought that people who
are depressed and/or anxious have lower levels of
serotonin and noradrenaline in the brain. It is not fully
understood how antidepressants work, but they may
help by increasing the levels of serotonin and
noradrenaline in the brain.
Rodomel XL is a treatment for adults with depression.
Rodomel XL is also a treatment for adults with social
anxiety disorder (fear or avoidance of social
situations). Treating depression or anxiety properly is
important to help you get better. If it is not treated,
your condition may not go away and may become
more serious and more difficult to treat.

2

WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RODOMEL XL

Do NOT take Rodomel XL
• If you are allergic to venlafaxine or to any of the other
ingredients of this medicine (listed in section 6 ).
• If you are also taking or have taken any time within
the last 14 days any medicines known as
irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease.
Taking an irreversible MAOI together with other
medicines, including Rodomel XL can cause
serious or even life-threatening side effects. Also,
you must wait at least 7 days after you stop taking
Rodomel XL before you take any MAOI (see also
the sections “Serotonin syndrome” and “Other
medicines and Rodomel XL”).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Rodomel XL
• If you use other medicines that taken together with
Rodomel XL could increase the risk of developing
serotonin syndrome (see the section “Other
medicines and Rodomel XL”).
• If you have eye problems, such as certain kinds of
glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told you have an abnormal heart
rhythm.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your
blood (hyponatraemia).
• If you have a tendency to develop bruises or a
tendency to bleed easily (history of bleeding
disorders), or if you are taking other medicines that
may increase the risk of bleeding e.g., warfarin
(used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your family
has had, mania or bipolar disorder (feeling
over-excited or euphoric).
• If you have a history of aggressive behaviour.
Rodomel XL may cause a sensation of restlessness or
an inability to sit or stand still. You should tell your
doctor if this happens to you.
Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety disorder you

Version:

can sometimes have thoughts of harming or killing
yourself. These may be increased when you first start
taking antidepressants, since these medicines all
take time to work, usually about two weeks, but
sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing
yourself or harming yourself
• If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in young adults (less than 25 years old)
with psychiatric conditions who were treated with
an antidepressant.
If you have thoughts of harming or killing yourself at
any time, contact your doctor or go to a hospital
straight away.
You may find it helpful to tell a relative or close friend
that you are depressed and ask them to read this
leaflet. You might ask them to tell you if they think
your depression is getting worse, or if they are
worried about changes in your behaviour.
Dry mouth
Dry mouth is reported in 10% of patients treated with
venlafaxine. This may increase the risk of tooth decay
(caries). Therefore, you should take special care in
your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to
Rodomel XL. Therefore, the dosage of your diabetes
medicines may need to be adjusted
Children and adolescents
Rodomel XL should normally not be used for children
and adolescents under 18 years. Also, you should
know that patients under 18 have an increased risk of
side effects, such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when they take
this class of medicines. Despite this, your doctor may
prescribe Rodomel XL for patients under 18 because
he/she decides that this is in their best interests. If
your doctor has prescribed Rodomel XL for a patient
under 18, and you want to discuss this, please go
back to your doctor. You should inform your doctor if
any of the symptoms listed above develop or worsen
when patients under 18 are taking Rodomel XL. Also,
the long-term safety effects concerning growth,
maturation and cognitive and behavioural
development of Rodomel XL in this age group has not
yet been demonstrated.
Other medicines and Rodomel XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Your doctor should decide whether you can take
Rodomel XL with other medicines.
Do not start or stop taking any medicines, including
those bought without a prescription, natural and
herbal remedies, before checking with your doctor or
pharmacist.
• Monoamine oxidase inhibitors which are used to
treat depression or Parkinson’s disease must not
be taken with Rodomel XL . Tell your doctor if you
have taken these medicines within the last 14 days.
(MAOIs: see the section “Before you take
Rodomel XL”)
• Serotonin syndrome: A potentially life-threatening
condition or Neuroleptic Malignant Syndrome
(NMS)-like reactions (see the section “Possible
Side Effects”), may occur with venlafaxine
treatment, particularly when taken with other
medicines
• Examples of these medicines include:
• Triptans (used to treat for migraine)
• Medicines to treat depression, for instance
SNRI, SSRIs, tricyclics, or medicines containing
lithium
• Medicines containing linezolid, an antibiotic
(used to treat infections)
• Medicines containing moclobemide, a reversible
MAOI (used to treat depression)
• Medicines containing sibutramine (used for
weight loss)
• Medicines containing tramadol (a pain-killer),
fentanyl, tapentadol, pethidine, or pentazocine
(used to treat severe pain)
• Medicines containing dextromethorphan (used
to treat coughing)
• Medicines containing methadone (used to treat
opioid drug addiction or severe pain)
• Medicines containing methylene blue (used to
treat high levels of methaemoglobin in the blood)
• Products containing St. John’s Wort (also called
Hypericum perforatum, a natural or herbal
remedy used to treat mild depression)
• Products containing tryptophan (used for
problems such as sleep and depression)
• Antipsychotics (used to treat a disease with
symptoms such as hearing, seeing or sensing
things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning and
becoming withdrawn).
Signs and symptoms of serotonin syndrome may
include a combination of the following: restlessness,
hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood
pressure, overactive reflexes, diarrhoea, coma,
nausea, vomiting.
In its most severe form, serotonin syndrome can
resemble Neuroleptic malignant syndrome (NMS).
Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating,
severe muscle stiffness, confusion, increased muscle
enzymes (determined by a blood test).
Tell your doctor immediately, or go to the casualty
department at your nearest hospital if you think
serotonin syndrome is happening to you.
You must tell your doctor if you are taking medicines
that can affect your heart rhythm.
Examples of these medicines include:
• Antiarrhythmics such as quinidine, amiodarone,
sotalol or dofetilide (used to treat abnormal heart
rhythm)
• Antipsychotics such as thioridazine (See also
Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin
(used to treat bacterial infections)
• Antihistamines (used to treat allergy)
The following medicines may also interact with
Rodomel XL and should be used with caution. It is
especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric
conditions)
• Metoprolol (a beta blocker to treat high blood
pressure and heart problems)
Tell your doctor if you are taking oral contraceptives.
Rodomel XL with food, drink and alcohol
Rodomel XL should be taken with food (see section 3
“How to take Rodomel XL”)
You should avoid alcohol while you are taking
Rodomel XL.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine. You should use Rodomel XL only after
discussing the potential benefits and the potential
risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are
on Rodomel XL. When taken during pregnancy, similar
drugs (SSRIs) may increase the risk of a serious
condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making the
baby breathe faster and appear bluish. These
symptoms usually begin during the first 24 hours after
the baby is born. If this happens to your baby you
should contact your midwife and/or doctor immediately.
If you are taking this medicine during pregnancy, let
your doctor know as your baby might have other
symptoms when it is born. These symptoms usually
being within 24 hours after the baby is born and
include not feeding properly, in addition to having

3

22 March 2016

TEVA UK Ref:

231-30-86688-Y LEA VENLAFAXINE (RODOMEL) A/S CAP TUK
trouble breathing. If your baby has these symptoms
when it is born and you are concerned, contact your
doctor and/or midwife who will be able to advise you.
Rodomel XL passes into breast milk. There is a risk of
an effect on the baby. Therefore, you should discuss
the matter with your doctor, and he/she will decide
whether you should stop breast-feeding or stop the
therapy with Rodomel XL.
Driving and using machines
Do not drive or use any tools or machines until you
know how Rodomel XL affects you.
Rodomel XL contains sucrose
This medicine contains sucrose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicinal product.

3

HOW TO TAKE RODOMEL XL

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The usual recommended starting dose for treatment
of depression and social anxiety disorder is 75 mg per
day. The dose can be raised by your doctor gradually,
and if needed, even up to a maximum dose of 375 mg
daily for depression. The maximum dose for social
anxiety disorder is 225 mg/day.
Take Rodomel XL at approximately the same time
each day, either in the morning or in the evening.
Capsules must be swallowed whole with fluid and not
opened, crushed, chewed or dissolved.
Rodomel XL should be taken with food.
If you have liver or kidney problems, talk to your
doctor, since your dose of Rodomel XL may need to
be different.
Do not stop taking Rodomal XL without talking to your
doctor (see the section “If you stop taking Rodomel XL”).
If you take more Rodomel XL than you should
Call your doctor or pharmacist immediately if you take
more than the amount of Rodomel XL prescribed by
your doctor.
The symptoms of a possible overdose may include a
rapid heart beat, changes in level of alertness
(ranging from sleepiness to coma), blurred vision,
seizures or fits, and vomiting.
If you forget to take Rodomel XL
If you miss a dose of your medicine then take it as
soon as you remember. However, if it is time for your
next dose, skip the missed dose and take only a single
dose as usual. Do not take more than the daily
amount of Rodomel XL that has been prescribed for
you in one day.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Rodomel XL
Do not stop taking your treatment or reduce the dose
without the advice of your doctor first, even if you feel
better. If your doctor thinks that you no longer need
Rodomel XL he/she may ask you to reduce your dose
slowly before stopping treatment altogether. Side
effects are known to occur when people stop using
Rodomal XL especially when Rodomel XL is stopped
suddenly or the dose is reduced too quickly. Some
patients may experience symptoms such as
tiredness, dizziness, light-headedness, headache,
sleeplessness, nightmares, dry mouth, loss of
appetite, nausea, diarrhoea, nervousness, agitation,
confusion, ringing in the ears, tingling, or rarely
electric shock sensations, weakness, sweating,
seizures or flu-like symptoms.
Your doctor will advise you on how you should
gradually discontinue Rodomel XL treatment. If you
experience any of these or other symptoms that are
troublesome, ask your doctor for further advice.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happen, do not take more
Rodomel XL, talk to your doctor immediately, or go to
the casualty department at your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or
breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing
sensations, sudden reddening of the skin and/or a
warm feeling
• Severe rash, itching, or hives (elevated patches of
red or pale skin that often itch)
• Signs and symptoms of serotonin syndrome which
may include restlessness, hallucinations, loss of
coordination, fast heart beat, increased body
temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea,
vomiting.
In its most severe form, serotonin syndrome can
resemble Neuroleptic malignant syndrome (NMS).
Signs and symptoms of NMS may include a
combination of fever, fast heart beat, sweating,
severe muscle stiffness, confusion, increased
muscle enzymes (determined by a blood test).
Other side effects that you should tell your doctor
about include:
• Coughing, wheezing, shortness of breath and a
high temperature
• Black (tarry) stools or blood in stools
• Yellow skin or eyes, itchiness or dark urine, which
may be symptoms of inflammation of the liver
(hepatitis)
• Heart problems, such as fast or irregular heart
rate, increased blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and
needles, movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and
euphoria (feeling unusually overexcited)
• Withdrawal effects (see the section “How to take
Rodomel XL, If you stop taking Rodomel XL”)
• Prolonged bleeding - if you cut or injure yourself, it
may take slightly longer than usual for bleeding to
stop.
Do not be concerned if you see small white balls or
granules in your stools after taking this medicine.
Inside Rodomel XL are spheroids (small white balls)
that contain the active ingredient (venlafaxine).
These spheroids are released from the capsule into
your stomach. As they travel through your stomach
and intestines, venlafaxine is slowly released. The
spheroid “shell” does not dissolve and is passed out
in your stools. So even though you may see spheroids
in your stools, your dose of medicine has been absorbed.
Complete side effect listing
Very common: may affect more than 1 in 10 people
• Dizziness, headache;
• Nausea, dry mouth;
• Sweating (including night sweats)
Common: may affect upto 1 in 10 people
• Appetite decreased
• Confusion; feeling separated (or detached) from
yourself; lack of orgasm; decreased libido;
nervousness; insomnia; abnormal dreams
• Drowsiness; tremor; pins and needles; increased
muscle tonus
• Visual disturbance including blurred vision; dilated
pupils; inability of the eye to automatically change
focus from distant to near objects
• Ringing in the ears (tinnitus)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties
passing urine
• Menstrual irregularities such as increased
bleeding or increased irregular bleeding; abnormal
ejaculation/orgasm (males); erectile dysfunction
(impotence)

Version:

3

• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon: may affect upto 1 in 100 people
• Hallucinations; feeling separated (or detached)
from reality; agitation; abnormal orgasm (females);
lack of feeling or emotion; feeling over-excited;
grinding of the teeth
• A sensation of restlessness or an inability to sit or
stand still; fainting; involuntary movements of the
muscles; impaired coordination and balance;
altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when
standing up too quickly)
• Shortness of breath
• Vomiting blood, black tarry stools (faeces) or blood
in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face,
mouth, tongue, throat area or hands and feet
and/or a raised itchy rash (hives) may be present;
sensitivity to sunlight; bruising; rash; abnormal hair
loss
• Inability to pass urine;
• Weight gain; weight loss
Rare: may affect upto 1 in 1000 people
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need
for sleep (mania)
Not known: frequency cannot be estimated from the
available data
• Reduced number of platelets in your blood, leading
to an increased risk of bruising or bleeding; blood
disorders which may lead to an increased risk of
infection
• Swollen face or tongue, shortness of breath or
difficulty breathing, often with skin rashes (this
may be a serious allergic reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours; cases of
suicidal ideation and suicidal behaviours have
been reported during venlafaxine therapy or early
after treatment discontinuation (see section 2,
Before you take Rodomel XL)
• Disorientation and confusion often accompanied
by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion
or agitation, and sweating, or if you experience
jerky muscle movements which you can't control,
these may be symptoms of serious conditions
known as neuroleptic malignant syndrome;
euphoric feelings, drowsiness, sustained rapid eye
movement, clumsiness, restlessness, feeling of
being drunk, sweating or rigid muscles, which are
symptoms of serotonin syndrome; stiffness,
spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or
irregular heart beat, which could lead to fainting;
unexpected bleeding, e.g. bleeding gums, blood in
the urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels
(broken veins)
• Coughing, wheezing, shortness of breath and a high
temperature, which are symptoms of inflammation
of the lungs associated with an increase in white
blood cells (pulmonary eosinophilia)
• Severe abdominal or back pains (which could
indicate a serious problem in the gut, liver or
pancreas)
• Itchiness, yellow skin or eyes, dark urine, or flu-like
symptoms, which are symptoms of inflammation of
the liver (hepatitis); slight changes in blood levels
of liver enzymes
• Skin rash, which may lead to severe blistering and
peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness
(rhabdomyolysis)
• Abnormal breast milk production
Rodomel XL sometimes causes unwanted effects that
you may not be aware of, such as increases in blood
pressure or abnormal heart beat; slight changes in
blood levels or liver enzymes, sodium or cholesterol.
More rarely Rodomel XL may reduce the function of
platelets in your blood leading to an increased risk of
bruising or bleeding. Therefore, your doctor may wish
to do blood tests occasionally, particularly if you have
been taking Rodomel XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5

HOW TO STORE RODOMEL XL

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Rodomel XL contains
• The active substance is venlafaxine.
Rodomel XL 37.5 mg prolonged release capsules
hard:
Each prolonged release capsule, hard, contains
37.5 mg venlafaxine (as 42.43 mg venlafaxine
hydrochloride).
Rodomel XL 75 mg prolonged release capsules hard:
Each prolonged release capsule, hard, contains 75 mg
venlafaxine (as 84.85 mg venlafaxine hydrochloride).
Rodomel XL 150 mg prolonged release capsules hard:
Each prolonged release capsule, hard, contains
150 mg venlafaxine (as 169.70 mg venlafaxine
hydrochloride).
• The other ingredients are:
Capsule contents:
Sugar spheres (saccharose, maize starch),
hydroxypropylcellulose, povidone K 30, ethylcellulose,
dibutyl sebacate, talc.
37.5 mg prolonged release capsules hard contain
gelatin, titanium dioxide, red iron oxide (E172).
75 mg prolonged release capsules hard contain
gelatin, titanium dioxide, red iron oxide (E172), yellow
iron oxide (E171).
150 mg prolonged release capsules hard contain
gelatin, titanium dioxide, red iron oxide (E172), yellow
iron oxide (E171).
What Rodomel XL looks like and contents of the pack
Rodomel XL 37.5 mg prolonged release capsules,
hard: opaque capsules, the upper part is
brownish-pink, the lower part is white.
Rodomel XL 75 mg prolonged release capsules, hard:
opaque, pale pink capsules.
Rodomel XL 150 mg prolonged release capsules, hard:
opaque, brownish-orange coloured capsules.
Pack sizes:
Boxes of 10, 14, 20, 28, 30, 50, 98, 100, 100x1
prolonged-release, capsules, hard, in blister packs.
Boxes of 50, 100 and 250 prolonged-release capsules,
hard, in HDPE capsule container.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: TEVA UK Limited,
Eastbourne, BN22 9AG.
Company responsible for manufacture: KRKA, d.d.,
Novo mesto, Šmarješka cesta 6, Novo mesto, 8501
Slovenia.
This leaflet was last approved in March 2016
86688-Y
PL 00289/1111-3

242907.02-GB

22 March 2016

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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